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Food, dietary supplement & cosmetics regulatory update, issue 7

On June 12, the U.S. Supreme Court unanimously reversed the Ninth Circuit, holding that POM Wonderful LLC's false advertising claim against the Coca-Cola Company for misleading advertising was not barred. POM challenged Coca-Cola's labeling for its "Pomegranate-blueberry blended juice," which contained more than 99 percent apple and grape juices. Coca-Cola responded that the Nutrition Labeling and Education Act of 1990 and implementing regulations, with which the labeling fully complied, override the Lanham Act, the federal false advertising law. The Ninth Circuit agreed with Coca-Cola, ruling that the more specific regulations governing food labels precluded this sort of false advertising claim. The Supreme Court disagreed, holding that the Lanham Act and the food labeling regulations coexist because there is no explicit restriction "in either statute [that] discloses a purpose to bar unfair competition claims like POM's." The opinion, authored by Justice Kennedy, also unanimously rejected the federal government's amicus argument that there should be a safe harbor for label statements that are specifically authorized by FDA regulations. Although the Court did not decide whether the label was actually misleading, the Court expressed concern that consumers in general do not receive adequate protection from false advertising. The Court also stated that competitors are better situated than government agencies to call attention to the kinds of deceptive marketing practices alleged in this case. Coca-Cola says it will continue to fight POM's accusation as the case goes to trial.

On June 3, FDA issued a revised Compliance Policy Guide Regarding Food Facility Registration for Human and Animal Food, which provides guidance for FDA staff on food facility registration requirements, as updated by the Food Safety Modernization Act ("FSMA"). FSMA amended the food facility registration requirements initially established by the Bioterrorism Act of 2002 to require additional registration information, biennial renewal, and assurance that FDA will be permitted to inspect the facility at certain times. FSMA also authorizes FDA to suspend registrations if FDA determines a food facility manufactured, processed, or otherwise handled a food with a reasonable probability of causing harm, and the facility was the cause of the reasonable probability or had reason to know about it. The publication largely reiterates FDA's Guidance for Industry: What You Need to Know About Registration of Food Facilities, which lays out FDA's authority to inspect a facility or suspend a facility's registration.

On June 2, FDA launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency. OpenFDA will make publicly available data accessible in a structured, computer-readable format. It provides a "search-based" application programming interface—the set of requirements that govern how one software application can talk to another—that allows users to find both structured and unstructured content online.

FDA Announces Read the Label Youth Outreach Campaign

On June 3, FDA announced its outreach campaign to teach young people (ages 9–13) to use the Nutrition Facts Label to make healthy food choices. Read the Label is the next generation of the FDA's Spot the Blockcampaign for "tweens." The new component features a guide and activities for afterschool and summer program leaders to help kids understand the Nutrition Facts Label on food packages. The comprehensive campaign also includes a wide assortment of downloadable, ready-to-use materials for community educators, families, and adolescents.

Two owners of an Iowa egg production facility will pay $6.8 million in fines as part of their plea agreement after pleading guilty to charges of bribery and introducing adulterated and misbranded food into interstate commerce. An employee admitted that he bribed at least one USDA official to allow for the sale of eggs that had been "red tagged" for failing to meet USDA standards. The release of the tainted eggs resulted in a Salmonella outbreak that affected tens of thousands of people and forced the recall of 550 million eggs.

On June 5, in response to the significant impact that porcine epidemic diarrhea virus and porcine deltacoronavirus are having on U.S. pork producers, USDA announced $26.2 million in new funding to combat these diseases. Additionally, USDA issued a Federal Order requiring the reporting of new detections of these viruses to its Animal and Plant Health Inspection Service or state animal health officials.

In the June 6 Federal Register, FDA confirmed the direct final rule revising the regulations on civil penalties will be effective on June 18. The direct final rule adjusts the penalty amounts for inflation and amends the process for initiating certain civil penalty administrative actions. The direct final rule was published in February. FDA is required to adjust the CMP at least once every four years under the Federal Civil Penalties Inflation Adjustment Act of 1990. The rule increased the maximum CMP amount anywhere from $1,000 to $25,000 per individual, $10,000 to $25,000 per violation, and $50,000 to $850,000 for multiple violations being adjudicated in a single proceeding.

USDA Proposes Rule Adding Terms for Biologics to Animal Test Results

In the May 30 Federal Register, USDA's Animal and Plant Health Inspection Service proposed amending the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on such products. USDA says defining these terms will clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test.Comments due July 29.

On June 9, FDA and EPA jointly announced the update of 2004 adviceregarding What You Need to Know About Mercury in Fish and Shellfish. The draft update appears in the June 11 Federal Register. The update contains both advice and supplemental questions and answers that go into more detail than the previous version of the document. Notably, the agencies adopt the Dietary Guidelines for Americans 2010, recommending that pregnant women and women who might become pregnant eat at least eight ounces of fish per week, provided the fish variety is low in mercury.

Bacterial contamination was the primary reason behind most food recalls over the last two weeks. Two dog food products were recalled for Salmonella contamination, as were chia seed and flaxseed powder products, ground pepper, and snack crackers. Minced crab meat was recalled for Listeria contamination. A dietary supplement maker also recently issued an expanded recall for its products that may contain undeclared pharmaceutical ingredients. Two companies issued a recalls of products packed in the wrong container that does not warn consumers that the product contains nuts. Lamb and sheep feed was recalled for high copper content.

USDA posted only one recall over the last two weeks: 363 pounds of boneless skinless chicken breasts with teriyaki seasoning were recalled due to misbranding because the product was formulated with wheat, yet the label claimed the product was gluten free.

For a complete list of product recalls, click here for FDA-regulated products, and here for USDA-regulated products.

Recent Warning Letters

FDA continues to post warning letters to dairy facilities for drug residues in edible tissues of animals sold for slaughter. FDA posted three such letters over the last two weeks. Seafood processing facilities also remain targets of FDA inspections with two letters posted for HACCP/CGMP violations for insufficient critical control points and limits that comply with regulations for temperature and acidity. FDA additionally posted three warning letters to the makers of several dietary supplements for therapeutic claims rendering the product a drug under the Food, Drug, and Cosmetic Act.

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